CN105188809A - Assembly for a drug delivery device comprising a feedback feature - Google Patents

Assembly for a drug delivery device comprising a feedback feature Download PDF

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Publication number
CN105188809A
CN105188809A CN201480013766.1A CN201480013766A CN105188809A CN 105188809 A CN105188809 A CN 105188809A CN 201480013766 A CN201480013766 A CN 201480013766A CN 105188809 A CN105188809 A CN 105188809A
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CN
China
Prior art keywords
feedback
actuator
assembly
tangibly
component
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Granted
Application number
CN201480013766.1A
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Chinese (zh)
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CN105188809B (en
Inventor
P·R·德雷珀
P·格里芬
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Sanofi Aventis Deutschland GmbH
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Sanofi Aventis Deutschland GmbH
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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/315—Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
    • A61M5/31565—Administration mechanisms, i.e. constructional features, modes of administering a dose
    • A61M5/31566—Means improving security or handling thereof
    • A61M5/3157—Means providing feedback signals when administration is completed
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/58—Means for facilitating use, e.g. by people with impaired vision
    • A61M2205/581—Means for facilitating use, e.g. by people with impaired vision by audible feedback
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/58—Means for facilitating use, e.g. by people with impaired vision
    • A61M2205/582—Means for facilitating use, e.g. by people with impaired vision by tactile feedback
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/315—Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
    • A61M5/31533—Dosing mechanisms, i.e. setting a dose
    • A61M5/31545—Setting modes for dosing
    • A61M5/31548—Mechanically operated dose setting member
    • A61M5/3155—Mechanically operated dose setting member by rotational movement of dose setting member, e.g. during setting or filling of a syringe
    • A61M5/31551—Mechanically operated dose setting member by rotational movement of dose setting member, e.g. during setting or filling of a syringe including axial movement of dose setting member
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/315—Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
    • A61M5/31565—Administration mechanisms, i.e. constructional features, modes of administering a dose
    • A61M5/31576—Constructional features or modes of drive mechanisms for piston rods
    • A61M5/31583—Constructional features or modes of drive mechanisms for piston rods based on rotational translation, i.e. movement of piston rod is caused by relative rotation between the user activated actuator and the piston rod
    • A61M5/31585—Constructional features or modes of drive mechanisms for piston rods based on rotational translation, i.e. movement of piston rod is caused by relative rotation between the user activated actuator and the piston rod performed by axially moving actuator, e.g. an injection button

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  • Health & Medical Sciences (AREA)
  • Vascular Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Hematology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)

Abstract

An assembly (60) for a drug delivery device (1) is provided, the assembly (60) comprising at least one feedback feature (2). The feedback feature (2) is configured to indicate the end of a dispense operation to a user by giving an audible and/or tactile feedback.

Description

For the assembly comprising feedback arrangement of delivery device
Technical field
The disclosure relates to a kind of assembly for delivery device.This assembly comprises feedback arrangement.
Summary of the invention
An object of the present invention is to provide a kind of assembly with improvement character for delivery device.
Provide a kind of assembly for delivery device, this assembly comprises at least one feedback arrangement.Feedback arrangement can be configured to can to listen and/or tactile feedback indicates the end of batch operation to user by providing.Feedback can be listened can be the click sound such as can heard.Tactile feedback can be the impact on the skin (particularly, the finger of user) of such as user.Alternatively, tactile feedback can be the vibration of a part for described assembly.Particularly, feedback can be well-defined signal.Particularly, feedback can release actuator and can take off device from the skin of user to user's instruction.
The advantage that feedback arrangement is configured to indicate batch operation to terminate, when batch operation completes, provides indicate clearly to user.Therefore, delivery device is used can be easy for user.In addition, dialling of delivery device selects degree of accuracy to increase.Particularly, before carrying all dosage, user can be forbidden such as by being taken off and interrupt distribution operation from skin by delivery device.In addition, this benefit being fed back to user visually impaired and providing extra.
According to an embodiment, assembly comprises actuator, and this actuator is configured to by user operation so that administered.When batch operation terminates actuator arrival terminal position, feedback can be produced.The terminal position of actuator can be the highest distance position of actuator.The part that term " highest distance position " can describe assembly is from the nearest position of the distribution end of delivery device.Particularly, when actuator is pressed against in delivery device completely, actuator can be in its terminal position.Actuator can be constructed to button.According to an embodiment, when actuator is close to its terminal position, feedback can be produced.
According to an embodiment, this at least one feedback arrangement comprises at least one mutation structure, this at least one mutation structure be configured to when it by compression more than spring sudden change during a fixed load, thus provide feedback for user.Therefore, mutation structure can produce earcon.Particularly, spring sudden change at the end of mutation structure is formed at batch operation.Particularly, mutation structure is configured to the spring sudden change when actuator arrives its terminal position.At first, between the compression period of mutation structure, the rigidity of mutation structure can keep quite constant.At certain some place, the rigidity of mutation structure can significantly reduce.Therefore, the power impelling the further deflection of mutation structure to need can reduce.This can the spring catastrophic behavior of mutagenesis structure.After batch operation, particularly, when mutation structure is no longer by compression, mutation structure can be relaxed to its original shape.When mutation structure relaxes, it can produce other earcon.
According to an embodiment, feedback arrangement, particularly mutation structure can comprise the shape of dome.Particularly, feedback arrangement can comprise the shape of arch dish.In one embodiment, feedback arrangement comprises at least one recess.Recess can be such as spill cut away.Due to this at least one recess, feedback arrangement can comprise sufficient flexibility.Therefore, feedback arrangement can be configured to when it is suddenlyd change more than spring during a fixed load by compression.Particularly, the size and shape of recess may affect the power impelling feedback arrangement to bounce needed for sudden change.In a further embodiment, mutation structure can without any recess.Therefore, feedback signal may be more obvious.
According to an embodiment, this at least one feedback arrangement comprises metal material.Alternatively, this at least one feedback arrangement can comprise plastic material.Preferably, feedback arrangement comprises elastomeric material.
According to an embodiment, assembly comprises and is configured to the interactional component with feedback arrangement.Component can be configured to move axially, particularly when it does not interact with feedback arrangement.Such as, during the starting stage of batch operation, component is configured to move vertically.The interaction that can move axially component and feedback arrangement can cause feeding back.Can move axially component can be shroud member.
According to an embodiment, feedback arrangement can be configured to be pressed between two parts of assembly.Such as, feedback arrangement can be crushed on actuator and can move axially between component.Alternatively, feedback arrangement can be crushed between housing and driver.
According to an embodiment, at least during the setting of dosage, component can move axially between two retainers relative to the housing of delivery device.Between the allotment period of dosage, particularly when actuator is close to its terminal position, component can be limited temporarily as mentioned above between these two retainers.Therefore, component can be fixed temporarily in the axial direction.Particularly, when component and feedback arrangement interact, that is, when actuator contact feedback arrangement, component can be fixed in the axial direction.
According to an embodiment, actuator and feedback arrangement especially interact with mutation structure.Particularly, in distributes, actuator can interact with feedback arrangement.Feedback arrangement, particularly mutation structure, can be disposed in actuator and can move axially between component.When actuator is when distributes is close to its terminal position, feedback arrangement can be clamped at actuator and can move axially between component.When actuator towards can move axially component move further time, feedback arrangement can be compressed by actuator.Particularly, when actuator moves towards another part further, the power on feedback arrangement increases.Particularly, in distributes, actuator can apply power on feedback arrangement.
According to an embodiment, assembly can comprise enhancing structure, and this enhancing structure is configured to the feedback strengthening feedback arrangement.Particularly, the volume can listening feedback can be increased.In addition or alternatively, tactile feedback can be strengthened.In addition, feedback can be listened can be strengthened by extra tactile feedback, or vice versa.According to an embodiment, strengthen structure and can be attached to and can move axially component.Particularly, the part that structure can be the integration that can move axially component is strengthened.Such as, strengthening structure can be the projection that can move axially component.Alternatively, strengthening structure can comprise flexible section, particularly can move axially the flexible section of component.In an alternative embodiment, strengthen another part that structure can be attached to assembly, such as, be attached to housing.
According to an embodiment, with feedback arrangement (particularly component can be moved axially) interactional component, comprise rigid section and flexible section.The flexible section of component can be formed at distributes and be compressed.Particularly, when the interaction that can move axially component and feedback arrangement (especially mutation structure) starts, flexible section can be compressed.According to an alternate embodiment, flexible section can be positioned at the fixed part office of delivery device, such as, at housing place.
According to an embodiment, component can be moved axially and be configured in axial direction launch when feedback arrangement (particularly mutation structure) spring sudden change.Particularly, when mutation structure spring sudden change, flexible section can in axial direction launch.Particularly, flexible section can be configured to launch along the direction towards device near-end.Near-end can be the distribution end one end farthest from device.Therefore, component can be moved axially and can compress mutation structure further.Due to flexible section, can move axially component can serve as spring member.Owing to being stored in the elasticity energy in flexible section and mutation structure, and due to the quality of these elements low, final feedback can than with the interactional perfect rigidity component of feedback arrangement more loudly and more high energy.Particularly, owing to strengthening structure, the rigidity at the contiguity constraint place on feedback arrangement can be reduced.Contiguity constraint can be the constraint of limit feedback structure movement.In addition, owing to strengthening structure, particularly owing to can move axially the flexibility of component, feedback arrangement can continue more long duration, because the energy that feedback arrangement is transferred to contact component decreases with larger amplitude vibration.
According to an embodiment, flexible section comprises at least one opening.Opening can be arranged in the sidewall that can move axially component.Due to this at least one opening, the flexibility of flexible section can be obtained.
According to an embodiment, feedback arrangement comprises opening, and wherein, at least one element of assembly extends through opening.Such as, actuator can extend through opening.
According to an embodiment, this at least one feedback arrangement comprises at least one tangibly structure, provides tactile feedback at the end of this this at least one tangibly structure is formed at batch operation to user.Tangibly structure can be constructed to strengthen structure.Particularly, except listened to the feedback provided by feedback arrangement or provided by further feedback arrangement, tactile feedback can be provided by tangibly structure.In addition, the tactile feedback that such as can provide to user due to the spring sudden change of mutation structure can be enhanced.Such as, the tactile feedback coming from mutation structure vibration can be strengthened by the tangibly structure of the direct skin contact with user.There is provided the advantage of the feedback arrangement of tactile feedback to be, also can provide to the user be under noisy environment or the user suffering from hearing impairment and feed back clearly.
According to an embodiment, give prominence to from actuator at the end of this at least one tangibly structure is formed at batch operation.
According to an embodiment, given prominence to by opening at the end of this at least one tangibly structure is formed at batch operation.Particularly, opening can be positioned at actuator.By giving prominence to from opening, tangibly structure can contact with the skin of user.Therefore, tactile feedback can be provided to user.
According to an embodiment, feedback arrangement comprises mutation structure, and wherein, when mutation structure spring sudden change, this at least one tangibly structure is given prominence to fast.Particularly, the spring sudden change of mutation structure can impel tangibly structure relative to the quick of actuator and well-defined movement.According to an embodiment, at the end of batch operation, tangibly structure can be fixed in the axial direction, and actuator can move towards the far-end of device, thus impels tangibly structure to give prominence to fast.According to further embodiment, at the end of batch operation, tangibly structure can move towards the near-end of device, and actuator moves towards the far-end of device simultaneously.Therefore, the speed that tangibly structure is given prominence to fast can increase.This can cause stronger tactile signal.Mutation structure can produce can be listened and tactile feedback.The feedback of mutation structure can be strengthened by tangibly structure.
According to an embodiment, this at least one tangibly structure can be attached to the interactional component with feedback arrangement, is particularly attached to and can moves axially component.Particularly, tangibly structure comprises the shape of the arm that can extend from movable member.In one embodiment, assembly can comprise multiple (such as, three) tangibly structure.Tangibly structure can be arranged to circumferentially around described component.According to an embodiment, this at least one tangibly structure extends from described component along proximal direction.
In addition, provide a kind of delivery device, this delivery device comprises the assembly constructed as previously described.Particularly, delivery device can comprise feedback arrangement, and this feedback arrangement is configured to can to listen and/or tactile feedback indicates the end of batch operation to user by providing.
Delivery device can be injection device.Delivery device can be pencil type apparatus.Delivery device can be variable dose device, makes user can the size of selective dose.Delivery device can be configured for multiple dose application scenario.Medicament can be transported to user by means of pin.Device can be fully assembled prepare at any time use state under be transported to user.Delivery device can be disposable apparatus.Term " disposable " means that delivery device can not be recycled after the medicament of available quantity has been carried from delivery device.Delivery device can be configured to carry liquid preparation.Medicament can be such as insulin.
Term used herein " medicament " (medicament) means the pharmaceutical formulation containing at least one pharmaceutically active compound,
Wherein in one embodiment, described pharmaceutically active compound has the molecular weight of as many as 1500Da and/or is peptide, protein, polysaccharide, vaccine, DNA, RNA, enzyme, antibody or its fragment, hormone or oligonucleotide, or the mixture of above-mentioned pharmaceutically active compound
Wherein in still another embodiment, described pharmaceutically active compound is for treating and/or preventing diabetes or the complication relevant with diabetes, such as diabetic retinopathy (diabeticretinopathy), thromboembolic disorders (thromboembolismdisorders) such as Deep venou or pulmonary thromboembolism, acute coronary syndrome (acutecoronarysyndrome, ACS), angina pectoris, myocardial infarction, cancer, degeneration of macula (maculardegeneration), inflammation, pollinosis, atherosclerosis and/or rheumatoid arthritis are useful,
Wherein in still another embodiment, described pharmaceutically active compound comprises at least one and is used for the treatment of and/or prevents diabetes or the peptide of the complication relevant with diabetes (such as diabetic retinopathy),
Wherein in still another embodiment, described pharmaceutically active compound comprises analog or the derivant of at least one insulin human or human insulin analogue or derivant, glucagon-like peptide (glucagon-likepeptide, GLP-1) or its analog or derivant or Exendin-3 (exedin-3) or exendin-4 (exedin-4) or Exendin-3 or exendin-4.
Insulin analog is Gly (A21), Arg (B31), Arg (B32) insulin human such as; Lys (B3), Glu (B29) insulin human; Lys (B28), Pro (B29) insulin human; Asp (B28) insulin human; Insulin human, wherein the proline of B28 position is replaced by Asp, Lys, Leu, Val or Ala and wherein the lysine of B29 position can replace with Pro; Ala (B26) insulin human; Des (B28-B30) insulin human; Des (B27) insulin human; With Des (B30) insulin human.
Insulin derivates is B29-N-myristoyl-des (B30) insulin human such as; B29-N-palmityl-des (B30) insulin human; B29-N-myristoyl human insulin; B29-N-palmitoyl human insulin; B28-N-myristoyl Lispro; B28-N-palmityl-Lispro; B30-N-myristoyl-ThrB29LysB30 insulin human; B30-N-palmityl-ThrB29LysB30 insulin human; B29-N-(N-palmityl-Υ-glutamy)-des (B30) insulin human; B29-N-(N-stone gallbladder acyl-Υ-glutamy)-des (B30) insulin human; B29-N-(ω-carboxyl heptadecanoyl)-des (B30) insulin human and B29-N-(ω-carboxyl heptadecanoyl) insulin human.
Exendin-4 means such as exendin-4 (1-39), and it is the peptide with following sequence: HHis-Gly-Glu-Gly-Thr-Phe-Thr-Ser-Asp-Leu-Ser-Lys-Gln-Met-Glu-Glu-Glu-Ala-Val-Arg-Leu-Phe-Ile-Glu-Trp-Leu-Lys-Asn-Gly-Gly-Pro-Ser-Ser-Gly-Ala-Pro-Pro-Pro-Ser-NH2.
Exendin-4 derivant is such as selected from following compound list:
H-(Lys) 4-desPro36, desPro37 exendin-4 (1-39)-NH2,
H-(Lys) 5-desPro36, desPro37 exendin-4 (1-39)-NH2,
DesPro36 [Asp28] exendin-4 (1-39),
DesPro36 [IsoAsp28] exendin-4 (1-39),
DesPro36 [Met (O) 14, Asp28] exendin-4 (1-39),
DesPro36 [Met (O) 14, IsoAsp28] exendin-4 (1-39),
DesPro36 [Trp (O2) 25, Asp28] exendin-4 (1-39),
DesPro36 [Trp (O2) 25, IsoAsp28] exendin-4 (1-39),
DesPro36 [Met (O) 14Trp (O2) 25, Asp28] exendin-4 (1-39),
DesPro36 [Met (O) 14Trp (O2) 25, IsoAsp28] exendin-4 (1-39); Or
DesPro36 [Asp28] exendin-4 (1-39),
DesPro36 [IsoAsp28] exendin-4 (1-39),
DesPro36 [Met (O) 14, Asp28] exendin-4 (1-39),
DesPro36 [Met (O) 14, IsoAsp28] exendin-4 (1-39),
DesPro36 [Trp (O2) 25, Asp28] exendin-4 (1-39),
DesPro36 [Trp (O2) 25, IsoAsp28] exendin-4 (1-39),
DesPro36 [Met (O) 14Trp (O2) 25, Asp28] exendin-4 (1-39),
DesPro36 [Met (O) 14Trp (O2) 25, IsoAsp28] exendin-4 (1-39),
Wherein-Lys6-NH2 group can be incorporated into the C end of exendin-4 derivant;
Or the exendin-4 derivant of following sequence
H-(Lys) 6-desPro36 [Asp28] exendin-4 (1-39)-Lys6-NH2,
DesAsp28Pro36, Pro37, Pro38 exendin-4 (1-39)-NH2,
H-(Lys) 6-desPro36, Pro38 [Asp28] exendin-4 (1-39)-NH2,
H-Asn-(Glu) 5desPro36, Pro37, Pro38 [Asp28] exendin-4 (1-39)-NH2,
DesPro36, Pro37, Pro38 [Asp28] exendin-4 (1-39)-(Lys) 6-NH2,
H-(Lys) 6-desPro36, Pro37, Pro38 [Asp28] exendin-4 (1-39)-(Lys) 6-NH2,
H-Asn-(Glu) 5-desPro36, Pro37, Pro38 [Asp28] exendin-4 (1-39)-(Lys) 6-NH2,
H-(Lys) 6-desPro36 [Trp (O2) 25, Asp28] exendin-4 (1-39)-Lys6-NH2,
H-desAsp28Pro36, Pro37, Pro38 [Trp (O2) 25] exendin-4 (1-39)-NH2,
H-(Lys) 6-desPro36, Pro37, Pro38 [Trp (O2) 25, Asp28] exendin-4 (1-39)-NH2,
H-Asn-(Glu) 5-desPro36, Pro37, Pro38 [Trp (O2) 25, Asp28] exendin-4 (1-39)-NH2,
DesPro36, Pro37, Pro38 [Trp (O2) 25, Asp28] exendin-4 (1-39)-(Lys) 6-NH2,
H-(Lys) 6-desPro36, Pro37, Pro38 [Trp (O2) 25, Asp28] exendin-4 (1-39)-(Lys) 6-NH2,
H-Asn-(Glu) 5-desPro36, Pro37, Pro38 [Trp (O2) 25, Asp28] exendin-4 (1-39)-(Lys) 6-NH2,
H-(Lys) 6-desPro36 [Met (O) 14, Asp28] exendin-4 (1-39)-Lys6-NH2,
DesMet (O) 14Asp28Pro36, Pro37, Pro38 exendin-4 (1-39)-NH2,
H-(Lys) 6-desPro36, Pro37, Pro38 [Met (O) 14, Asp28] exendin-4 (1-39)-NH2,
H-Asn-(Glu) 5-desPro36, Pro37, Pro38 [Met (O) 14, Asp28] exendin-4 (1-39)-NH2,
DesPro36, Pro37, Pro38 [Met (O) 14, Asp28] exendin-4 (1-39)-(Lys) 6-NH2,
H-(Lys) 6-desPro36, Pro37, Pro38 [Met (O) 14, Asp28] exendin-4 (1-39)-(Lys) 6-NH2,
H-Asn-(Glu) 5desPro36, Pro37, Pro38 [Met (O) 14, Asp28] exendin-4 (1-39)-(Lys) 6-NH2,
H-Lys6-desPro36 [Met (O) 14, Trp (O2) 25, Asp28] exendin-4 (1-39)-Lys6-NH2,
H-desAsp28Pro36, Pro37, Pro38 [Met (O) 14, Trp (O2) 25] exendin-4 (1-39)-NH2,
H-(Lys) 6-desPro36, Pro37, Pro38 [Met (O) 14, Asp28] exendin-4 (1-39)-NH2,
H-Asn-(Glu) 5-desPro36, Pro37, Pro38 [Met (O) 14, Trp (O2) 25, Asp28] exendin-4 (1-39)-NH2,
DesPro36, Pro37, Pro38 [Met (O) 14, Trp (O2) 25, Asp28] exendin-4 (1-39)-(Lys) 6-NH2,
H-(Lys) 6-desPro36, Pro37, Pro38 [Met (O) 14, Trp (O2) 25, Asp28] exendin-4 (S1-39)-(Lys) 6-NH2,
H-Asn-(Glu) 5-desPro36, Pro37, Pro38 [Met (O) 14, Trp (O2) 25, Asp28] exendin-4 (1-39)-(Lys) 6-NH2;
Or the pharmaceutically acceptable salt of any one exendin-4 derivant aforementioned or solvate.
Hormone is such as at RoteListe, ed.2008, the pituitary hormone (hypophysishormones) listed in 50th chapter or hypothalamic hormone (hypothalamushormones) or modulability bioactive peptide (regulatoryactivepeptides) and their antagonist, such as promoting sexual gland hormone (follitropin (Follitropin), metakentrin (Lutropin), chorionic-gonadotropin hormone (Choriongonadotropin), Menotrophins (Menotropin)), Somatropine (growth hormone (Somatropin)), Desmopressin (Desmopressin), terlipressin (Terlipressin), gonadorelin (Gonadorelin), triptorelin (Triptorelin), leuprorelin (Leuprorelin), buserelin (Buserelin), nafarelin (Nafarelin), goserelin (Goserelin).
Polysaccharide is glucosaminoglycan (glucosaminoglycane), hyaluronic acid (hyaluronicacid), heparin, low molecular weight heparin or ultra-low molecular weight heparin or derivatives thereof such as, or the sulphation of aforementioned polysaccharide, such as poly-sulfated form, and/or the acceptable salt of its pharmacy.An example of the pharmaceutically acceptable salt of poly-sulfated low molecular weight heparin is Enoxaparin Sodium (enoxaparinsodium).
Antibody is spherical plasma proteins (~ 150kDa), also referred to as immunoglobulin, and its total a kind of base structure.Because they have the sugar chain being added into amino acid residue, so they are glycoproteins.The basic function unit of each antibody is immunoglobulin (Ig) monomer (only containing an Ig unit); The antibody of secretion also can be the dimer with two Ig unit as IgA, there are four Ig unit the tetramer as the IgM of bony fish (teleostfish) or there are five Ig unit pentamer as mammiferous IgM.
Ig monomer is " Y " shape molecule, and it is made up of four polypeptide chains; Article two, the light chain that identical heavy chain is identical with two, they are connected by the disulfide bond between cysteine residues.Every bar heavy chain is about 440 aminoacid; Every bar light chain is about 220 aminoacid.Every bar heavy chain and light chain are all containing intrachain disulfide bond, and intrachain disulfide bond stablizes the folding of them.Every bar chain is all by being called that the domain in Ig territory is formed.Different categories (such as, variable or V, constant or C) containing 70-110 aminoacid of having an appointment, and is included into according to their size and functional classification in these territories.They have distinctive immunoglobulin folding, and wherein two β lamellas create a kind of " sandwich " shape, and this shape is kept together by the interaction between the cysteine guarded and other charged aminoacid.
Mammal Ig heavy chain has five types, is expressed as α, δ, ε, γ and μ.The isotype of the type decided antibody of the heavy chain existed; These chains can find respectively in IgA, IgD, IgE, IgG and IgM antibody.
Size and the composition of different heavy chains are different; α and γ contains about 450 aminoacid, and δ contains about 500 aminoacid, and μ and ε has about 550 aminoacid.Every bar heavy chain has Liang Ge district, i.e. constant region (CH) and variable region (VH).In species, constant region is substantially the same in all antibody of same isotype, but is different in the antibody of different isotype.Heavy chain γ, α and δ have the constant region comprising three series connection Ig territories, and for increasing the hinge region of flexibility; Heavy chain μ and ε has the constant region comprising four immunoglobulin domain.The variable region of heavy chain is different in the antibody by different B Hemapoiesis, but it is identical for cloned all antibody of generation by single B cell or single B cell for.The variable region of every bar heavy chain is about 110 amino acid longs and comprises single Ig territory.
In mammal, there is the light chain immunoglobulin of two types, be expressed as λ and κ.Light chain has two continuous print territories: a constant domain (CL) and a variable domain (VL).Light chain is grown up about 211 to 217 aminoacid.Each antibody contains two light chains, and they are always identical; Only there is the light chain of a type in each antibody in mammal, or κ or λ.
As detailed above, although the general structure of all antibody is closely similar, the peculiar property of given antibody is determined by variable (V) district.More particularly, variable loop--it above and on heavy chain (VH) respectively has three at light chain (VL)--is responsible for conjugated antigen, i.e. antigenic specificity.These rings are called as complementary determining region (ComplementarityDeterminingRegions, CDRs).Because all have contribution to antigen binding site from the CDR in VH and VL territory, so be the combination of heavy chain and light chain, instead of wherein independent one, determine final antigenic specificity.
" antibody fragment " containing at least one Fab as defined above, and presents the function substantially the same with the complete antibody of derivative antibody fragment and specificity.With papain (papain) restrictive proteolytic digestion, Ig prototype is cracked into three fragments.Two identical amino end segment are Fab (Fab), and each fragment contains a complete L chain and only about half of H chain.3rd fragment is FC (Fc), and its size is similar but what comprise is that half of the carboxyl terminal of two heavy chains, and possesses interchain disulfide bond.Fc contains sugar, complement-binding site and FcR binding site.Restrictive pepsin (pepsin) digestion produces single F (ab') 2 fragment containing two Fab and hinge region, and it comprises H-H interchain disulfide bond.F (ab') 2 is bivalence for antigen combines.The disulfide bond of F (ab') 2 can cracking to obtain Fab'.In addition, can by the variable region fusion of heavy chain and light chain to together with to form single chain variable fragment (scFv).
Pharmaceutically acceptable salt such as acid-addition salts and basic salt.Acid-addition salts is HCl or HBr salt such as.Basic salt such as has the cation being selected from alkali or alkaline earth, such as Na+ or K+ or Ca2+, or the salt of ammonium ion N+ (R1) (R2) (R3) (R4), wherein R1 to R4 is independently of one another: hydrogen, optional C1-C6 alkyl, optional C2-C6 thiazolinyl, the C6-C10 aryl optionally replaced or the optional C6-C10 heteroaryl replaced replaced replaced.More examples of pharmaceutically acceptable salt are at " Remington'sPharmaceuticalSciences " 17.ed.AlfonsoR.Gennaro (Ed.), MarkPublishingCompany, Easton, Pa., U.S.A., in 1985 and describe in EncyclopediaofPharmaceuticalTechnology.
Pharmaceutical acceptable solvents compound such as hydrate.
Accompanying drawing explanation
Further feature, improvement and suitability become obvious below in conjunction with accompanying drawing in the description of exemplary embodiment.
Fig. 1 illustrates the sectional view of delivery device,
Fig. 2 illustrates the proximal section of delivery device,
Fig. 3 A illustrates mutation structure,
Fig. 3 B illustrates the further embodiment of mutation structure,
Fig. 4 illustrates and can move axially component,
Fig. 5 illustrates the proximal section of the further embodiment of delivery device,
Fig. 6 illustrates the embodiment be under different conditions of Fig. 5,
Fig. 7 illustrates the embodiment of Fig. 5, and wherein, actuator is shown as transparent,
Fig. 8 illustrates the embodiment of Fig. 5, and wherein, actuator leaves from device.
Detailed description of the invention
Fig. 1 illustrates delivery device 1.Particularly, delivery device 1 is injection device.Delivery device 1 is variable dose device, makes user can the size of selective dose.Delivery device 1 is configured for multiple dose application scenario.Device can be fully assembled prepare at any time use state under be transported to user.Device has low component number, for being attracting especially for the application of installation occasion of cost sensitivity.
Delivery device 1 comprises housing 3, interior main body 4, actuator 5, indicator 6, driver 7, piston rod 9, piston 10, final dose retainer 11 and cartridge case 13.The pin assembly comprising needle stand and pin cover can be provided by as additional components.
Housing 3 is elements of tubulose substantially.The distal part of housing 3 forms the cartridge case bracket 14 for receiving cartridge case 13.
Interior main body 4 is elements of tubulose substantially.Interior main body 4 to be received in housing 3 and to be for good and all fixed therein any relative motion of preventing interior main body 4 relative to housing 3.External screw thread 15 is arranged on the outer surface of interior main body 4.At its far-end, interior main body 4 comprises other screw thread 16.
Actuator 5 is constructed to button.Actuator 5 can move relative to housing 3 and interior main body 4 on turning to and axially.Actuator 5 is arranged in the proximal end of delivery device 1.Actuator 5 is configured to be operated to distribute the medicament of doses.
Indicator 6 is elements of tubulose substantially.Particularly, indicator 6 is constructed to rotating member 43.Particularly, indicator 6 is formed between the setting of dosage and allotment period and rotates relative to housing 3.Indicator 6 is arranged concentrically around interior main body 4.Particularly, indicator 6 comprises female thread 19, and female thread 19 engages with the external screw thread 15 of interior main body 4.Therefore, indicator 6 is arranged between interior main body 4 and housing 3.The outer surface of indicator 6 provides (such as, printing) a series of numeral.Number arrangement, on helix, makes can only see a numeral or several numeral by the window 12 of housing 3.The amount of numeral instruction setting dosage.At the end of dose distribution operation, indicator 6 may return in its initial position, thus indicates the end of batch operation to user.
Piston rod 9 is constructed to driving screw.Particularly, piston rod 9 comprises the contrary screw thread of two rotation directions overlapping each other.The female thread 16 of main body 4 in a joint in the screw thread of piston rod 9.
Driver 7 is elements of tubulose substantially.The inner surface of driver 7 has female thread 18, and female thread 18 engages with in the external screw thread of piston rod 9.Driver 7 is positioned at main body 4 at least in part.The distal region of driver 7 has external screw thread 17.Rotate relative to housing 3 during driver 7 is formed at the setting of dosage and move axially.Between the allotment period of dosage, driver 7 can move in the axial direction relative to housing 3, and fixing on turning to.
Final dose retainer 11 is arranged between interior main body 4 and driver 7.The external screw thread 17 of the female thread engagement with driver 7 of final dose retainer 11.Final dose retainer 11 is configured to forbid that the dosage set is greater than remaining pharmaceutical quantities in cartridge case 13.This is by final dose retainer 11 the realizing against structure against driver 7 when the dosage set corresponds to remaining pharmaceutical quantities in cartridge case 13.Final dose retainer 11 is constructed to nut.
In order to set dosage, user's revolving actuator 5.During the setting of dosage, indicator 6 and driver 7 are fixing relative to actuator 5 on turning to.Therefore, actuator 5, indicator 6 and driver 7 spin out from housing 3.Therefore, during the setting of dosage, driver 7 rotates along piston rod 9 in a proximal direction, and piston rod 9 relative to housing 3 in the axial direction and be fixing on turning to.Indicator 6 rotates along the screw thread 15 of interior main body 4.
In order to administered, user operation actuator 5.Particularly, actuator 5 is pushed towards the distribution end direction of device.Between the allotment period of dosage, actuator 5 and driver 7 are secured together on turning to.During dose distribution, indicator 6 can rotate relative to actuator 5 and driver 6.Therefore, indicator 6 can rotate and be back to its initial position and the end indicating batch operation to user.When operate actuator 5, driver 7 also moves along the direction towards the distribution end of device.Therefore, piston rod 9 moves axially to distribute the medicament of doses along distal direction.Particularly, rotate between the allotment period that piston rod 9 is formed at dosage and move axially.When actuator 5 has been operated and arrived terminal position, provide feedback to user.Particularly, feedback can indicate the end of batch operation.The terminal position of actuator 5 can be its farthest side position.Particularly, actuator 5 is in its terminal position when it is pressed completely.
In Fig. 2 to Fig. 7, the different embodiments of the feedback arrangement that batch operation can be indicated to terminate to user are shown.Particularly, Fig. 2 and Fig. 5 to Fig. 7 illustrates the different assemblies 60 of the delivery device 1 comprising the different embodiment of feedback arrangement 2.Embodiment illustrates under the background of delivery device 1 as shown in Figure 1, but is not limited to this situation.Particularly, also feedback arrangement 2 can be used in reusable device or in the device with different driving mechanism.
Fig. 2 illustrates the proximal section of the delivery device 1 comprising feedback arrangement 2.Feedback arrangement 2 comprises mutation structure 35.Mutation structure 35 is constructed to the dome that suddenlys change.Mutation structure 35 comprises opening 33, and wherein, actuator 5 extends through opening 33.
Mutation structure 35 is shown in figure 3 a.Mutation structure 35 comprises metal material or is made up of metal material.Mutation structure 35 is constructed to arch dish.In addition, mutation structure 35 comprises at least one recess 34.Recess 34 is constructed to concave shaped cavity.Particularly, mutation structure 35 comprises four recesses 34.Due to recess 34, mutation structure 35 comprises sufficient flexibility.Mutation structure 35 is configured to when it is suddenlyd change more than spring during a fixed load by compression.Therefore, mutation structure 35 produces and can listen click sound.Particularly, at the end of batch operation, can provide to user and can listen and tactile feedback.
In alternate embodiment in figure 3b, mutation structure 35 is constructed to the arch dish without any recess.Therefore, mutation structure 35 can comprise high rigidity.Therefore, feedback signal can be more obvious.Particularly, mutation structure 35 is constructed to hogring.Particularly, mutation structure 35 comprises opening.
As shown in Figure 2, mutation structure 35 is operated by the moved axially component 50 shown in Fig. 4.Particularly, can move axially component 50 is shroud members 24.Shroud member 24 is arranged between actuator 5 and indicator 6.Shroud member 24 can move axially between two retainers 44,45 relative to actuator 5.Actuator 5 and shroud member 24 are pushed to head on open in these retainers 44,45 one to shroud member 24 prestrain by mutation structure 35.Particularly, a retainer 44 is provided by housing 3, and another retainer 45 is provided by actuator 5.When actuator 5 is close to its terminal position, shroud member 24 contacts the retainer 44 at housing 3 place.When making actuator 5 move further towards its terminal position, mutation structure 35 is compressed.Therefore, mutagenesis structure 35 is suddenlyd change, thus produces and can listen click sound.Particularly, at the end of batch operation, can provide to user and can listen clearly and tactile feedback.After batch operation, when user's release actuator 5, mutation structure 35 can be relaxed to its unpressed form.When mutation structure 35 relaxes, it can produce other listening and palpable feedback.
In the illustrated embodiment, can move axially component 50, particularly shroud member 24 comprises enhancing structure 51.Strengthen structure 51 and comprise rigid section 37 and flexible section 36.Rigid section 37 is arranged in the far-end of shroud member 24, and flexible section 36 is arranged in the proximal end of shroud member 24.Flexible section 36 comprises at least one opening 38.Particularly, flexible section 36 comprises three openings 38.In addition, flexible section 36 comprises at least one (particularly, three) flexing arm 41.Flexing arm 41 is configured to flexibly deflect when in axial direction applying pressure on shroud member 24.In an alternative embodiment, flexing arm 41 radially inwardly can extend the inner space more effectively to use shroud member 24.Particularly, when in axial direction applying power on shroud member 24, shroud member 24 is compressed.Therefore, shroud member 24 serves as spring member.
In addition, flexible section 36 comprises end ring 42.End ring 42 connects flexing arm 41.End ring 42 comprises contact surface 43, and this contact surface 43 is configured at least at the end of batch operation, contact mutation structure 35.Alternatively, contact surface 43 can comprise the several contact points with mutation structure.Therefore, can reduce the constraint that mutation structure 35 vibrates.Therefore, can to listen and tactile feedback can increase.In an alternative embodiment, flexing arm 41 can be supported oneself in the proximal end of shroud member 24.In this case, contact surface 43 will be positioned at the free end of flexing arm 41.
As mentioned above, when actuator 5 is when distributes is close to its terminal position, particularly when actuator 5 interacts with feedback arrangement 2, shroud member 24 contacts the retainer 44 at housing 3 place.When actuator 5 moves towards its terminal position further, the flexible section 36 of mutation structure 35 and shroud member 24 is compressed simultaneously.When mutation structure 35 by compression more than a fixed load time, its rigidity promptly reduces.This will impel the flexible section 36 of shroud member 24 promptly to launch and compresses mutation structure 35 completely.Therefore, mutagenesis structure 35 is suddenlyd change, thus produces and can listen click sound.Particularly, at the end of batch operation, can provide to user and can listen clearly and tactile feedback.Tactile feedback comprises vibration and the motion of actuator 5, and this vibration and motion are transferred to user, such as, transfer to the finger of user.Quality due to shroud member 24 and mutation structure 35 is low and store a large amount of elasticity energy in shroud member 24 and mutation structure 35, and compared with utilizing the embodiment of perfect rigidity shroud member 24, final feedback may more loudly and more high energy.
By reducing the rigidity at the contiguity constraint place on mutation structure 35, the flexibility of shroud member 24 also can improve the intensity of feedback.Contiguity constraint on mutation structure 35 is the constraint that restriction mutation structure 35 moves or vibrates.Compared with utilizing the embodiment of perfect rigidity shroud member 24, this can be allowed mutation structure 35 with larger amplitude vibration by the energy reducing to transfer to contact component and be continued the longer persistent period.This causes more multi-energy to transfer to air and more loud feedback.
When being released by shroud member 24 load be applied on mutation structure 35 after batch operation, mutation structure 35 sudden change is back to its uncompressed form.Therefore, mutation structure 35 can produce other listening and palpable feedback.Shroud member 24 also relaxes and is back to its uncompressed form.
Fig. 5 illustrates the portions of proximal of the delivery device 1 of the different embodiments comprising feedback arrangement 2.In this embodiment, actuator 5 comprises at least one (particularly, three) opening 39.Opening 39 is arranged in the proximal face place of actuator 5.At least one tangibly structure 40 is comprised according to the feedback arrangement of this embodiment.Particularly, the quantity of tangibly structure 40 corresponds to the quantity of the opening 39 in actuator.Tangibly structure 40 is constructed to projection.Tangibly structure 40 is arranged in and can moves axially component 50 place, particularly, at shroud member 24 place.Particularly, tangibly structure 40 can be the integrated part of shroud member 24.In embodiment shown in Fig. 5 to Fig. 7, shroud member 24 is perfect rigidity components.In an alternative embodiment, according to the shroud member 24 described by reference Fig. 4, shroud member 24 can comprise flexible section and rigid section.Therefore, tangibly structure 40 extends and the speed hitting the skin of user can increase.Therefore, tactile feedback can be very strong and clearly defined.
Fig. 6 illustrates the portions of proximal when actuator 5 activates according to the delivery device of Fig. 5.Particularly, after batch operation, actuator 5 is in its terminal position.The terminal position of actuator 5 can be its farthest side position.Particularly, actuator 5 is in its terminal position when it is pressed completely.When make actuator 5 along distal direction move and close to its terminal position time, the projection of tangibly structure 40 is configured to the mobile opening 39 by actuator 5.Therefore, tangibly structure 40 is given prominence to from delivery device 1 (particularly from actuator 5).Therefore, at the end of batch operation, tangibly structure 40 provides tactile feedback to user.Particularly, in distributes, with thumb, user such as can feel that feedback arrangement 2 is given prominence to from actuator 5.
Fig. 7 illustrates the schematic diagram of the portions of proximal of delivery device.In order to understand this mechanism better, actuator 5 is shown as transparent.Delivery device 1 comprises mutation structure 35, with reference to Figure 2 and 3 as described.The recess 34 of tangibly structure 40 extend through mutation structure 35.When mutation structure 35 bounces sudden change, actuator 5 moves along the direction towards the distribution end of device rapidly.Therefore, tangibly structure 40 projects through rapidly the opening 39 provided by actuator 5.Therefore, tangibly structure 40 directly hits the skin of user.Therefore, for user provides clearly defined tactile feedback.This tactile feedback improves the clarity of signal, especially in noisy environment or for the user suffering from hearing impairment.
In fig. 8, show the portions of proximal of the delivery device shown in Fig. 7, wherein actuator 5 leaves from device.
Reference numeral
1 delivery device
2 feedback arrangements
3 housings
Main body in 4
5 actuators
6 indicators
7 drivers
8 actuators
9 piston rods
10 pistons
11 final dose components
12 windows
13 cartridge cases
14 cartridge holder
The screw thread of main body in 15
The screw thread of main body in 16
The screw thread of 17 drivers
The screw thread of 18 drivers
The screw thread of 19 indicators
24 shroud members
26 longitudinal axis
33 openings
34 recesses
35 mutation structures
36 flexible sections
37 rigid sections
38 openings
39 openings
40 tangibly structures
41 flexing arms
42 end rings
43 contact surfaces
44 retainers
45 retainers
50 components
51 strengthen structure
60 assemblies

Claims (17)

1. the assembly for delivery device, this assembly (60) comprises at least one feedback arrangement (2), this at least one feedback arrangement (2) is configured to can to listen and/or tactile feedback indicates the end of batch operation to user by providing, and comprise and strengthen structure (51), this enhancing structure (51) is configured to the feedback strengthening feedback arrangement (2).
2. assembly according to claim 1, wherein, strengthens the structure that structure is the tactility for increasing the audibility and/or increase tactile feedback can listening feedback.
3. the assembly according to any one in claim 1 or 2, is characterized in that, the component moved axially during assembly comprises the starting stage being formed at batch operation, wherein, strengthens structure and comprises the flexible section that can move axially component.
4. the assembly according to any one in claims 1 to 3, comprise actuator (5), this actuator (5) is configured to carry out operating so that administered, and wherein, when actuator (5) terminates to arrive terminal position in batch operation, feedback produces.
5. assembly according to claim 4, wherein, feedback arrangement (2) comprises mutation structure, and this mutation structure comprises opening, wherein, actuator (5) extend through opening.
6. the assembly according to any one in aforementioned claim, wherein, described at least one feedback arrangement (2) comprises at least one mutation structure (35), described at least one mutation structure (35) is configured to when it is suddenlyd change more than spring during a fixed load by compression, thus provides feedback to user.
7. the assembly according to any one in aforementioned claim, wherein, feedback arrangement (2) comprises the shape of dome.
8. the assembly according to any one in aforementioned claim, comprises and being configured to and feedback arrangement (2) interactional component (50).
9. assembly according to claim 8, wherein, component (50) is configured in axial direction launch when mutation structure (35) spring sudden change.
10. the assembly described in any one according to Claim 8 to 9, wherein, component (50) comprises rigid section and flexible section.
11. assemblies according to any one in aforementioned claim, wherein, this at least one feedback arrangement (2) comprises metal material.
12. assemblies according to any one in aforementioned claim, wherein, this at least one feedback arrangement (2) comprises at least one tangibly structure (40), provides tactile feedback at the end of this at least one tangibly structure is formed at batch operation to user.
13. assemblies according to claim 12, comprise actuator (5), this actuator (5) is configured to activated to distribute the medicament of doses, wherein, give prominence to from actuator (5) at the end of this at least one tangibly structure (40) is formed at batch operation.
14. assemblies according to claim 12 or 13, wherein, this at least one tangibly structure (40) is configured to be given prominence to by opening (39).
15., according to claim 12 to the assembly described in any one in 14, comprise mutation structure (35), and wherein, when mutation structure (35) spring sudden change, this at least one tangibly structure (40) is given prominence to fast.
16. according to claim 12 to the assembly described in any one in 15, comprise component (50), wherein, this at least one tangibly structure (40) is attached to component (50), and this at least one tangibly structure (40) extends from component (50) along proximal direction.
17. 1 kinds of delivery devices, comprise the assembly according to any one in claim 1 to 16.
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